Anthony J. DeStefano Ph.D.
Consultant - Former USP Sr. Vice President of General Chapters and Healthcare Quality Standards

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Biography

Tony DeStefano began his career at Procter & Gamble in mass spectrometry. After P&G acquired Norwich Eaton Pharmaceuticals, he managed Physical Measurement and Method Development Sections for several years, after which he established Norwich’s first Bioanalytical Section. In 2002, he returned to Cincinnati to manage the bioanalysis programs for multiple clinical studies. He has spoken and written extensively in the areas of regulated bioanalysis and analytical and bioanalytical validation and outsourcing. In 2008 he joined the US Pharmacopeia as its Vice President of General Chapters. At USP, he led initiatives to maintain, update and redesign its General Chapters. He was promoted to Senior Vice President and had responsibility for the Health Care Quality Standards, Excipients, Dietary Supplements and Food Ingredients groups. He was a USP representative to the ICH Q3D Expert Working Group on metal impurities and the Pharmacopoeial Discussion Group (PDG). The purpose of the PDG, with representatives from the European Pharmacopoeia, the Japanese Pharmacopoeia, the U.S. Pharmacopeia and the World Health Organization as an observer, is to harmonize pharmacopeial standards (excipient monographs and selected general chapters, including elemental impurities) in three major regions of the world. While at USP, he lead the effort to replace USP Heavy Metals <231> with the new general chapters <232> and <233>. He has spoken extensively regarding these chapters both domestically and internationally. He was a co-developer of the initial USP training course on elemental impurities and served as the trainer for the first session. He is currently a consultant through YourEncore and Nuventra, and personally, consulting on analytical, bioanalytical, compendial and quality-related issues. He is a member of the American Chemical Society (ACS), Chair of the Board of the Product Quality Research Institute (PQRI), and a past president of the American Association of Pharmaceutical Scientists (AAPS).

Publications involving elemental impurities

- USP Metals Testing. S. Schuber, A.J. DeStefano, R.L. Williams, W. F. Koch, D. R. Abernethy, Pharm. Technology, 32(11):152-153 (2008).
- Metal Impurities in Food and Drugs. D.R. Abernethy, A.J. DeStefano, T.L. Cecil, K. Zaidi, R.L. Williams and the USP Metal Impurities Advisory Panel, Pharm. Res., Vol. 27(5), 750-755 (2010).
- The Impact of USP’s New Elemental Impurities Standards on Manufacturers, Suppliers and Contract Laboratories, Anthony DeStefano and Kahkashan Zaidi, Pharmaceutical Outsourcing, October 5, 2012.
- Elemental Impurities Control, Anthony J. DeStefano and Kahkashan Zaidi, Contract Pharma, October, 2012.